Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
ZEPATIER 50 mg/100 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Beige, oval tablet of dimensions 21 mm x 10 mm debossed with “770” on one side and plain on the other. |
Each film-coated tablet contains 50 mg elbasvir and 100 mg grazoprevir.
Excipients with known effect: Each film-coated tablet contains 87.02 mg of lactose (as monohydrate) and 69.85 mg of sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Elbasvir |
|
|
| Elbasvir and Grazoprevir |
Elbasvir/grazoprevir combines two direct-acting antiviral agents with distinct mechanisms of action and nonoverlapping resistance profiles to target HCV at multiple steps in the viral lifecycle. Elbasvir is an inhibitor of HCV NS5A, which is essential for viral RNA replication and virion assembly. Grazoprevir is an inhibitor of the HCV NS3/4A protease which is necessary for the proteolytic cleavage of the HCV encoded polyprotein (into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins) and is essential for viral replication. |
|
| Grazoprevir |
|
| List of Excipients |
|---|
|
Tablet core: Sodium laurilsulfate Film-coating: Lactose monohydrate |
The tablets are packaged into a carton containing two (2) cardboard cards, each cardboard card containing (2) 7-count aluminium blisters sealed in a cardboard card for a total of 28 tablets.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
EU/1/16/1119/001
Date of first authorisation: 22 July 2016
Date of latest renewal: 06 May 2021
| Drug | Countries | |
|---|---|---|
| ZEPATIER | Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Singapore, United Kingdom, United States |
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